NCT00557505

Brief Summary

P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

March 26, 2012

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

November 12, 2007

Results QC Date

January 10, 2012

Last Update Submit

February 21, 2012

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose (MTD)

    Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle

  • Recommended Phase-2 Dose (RP2D)

    Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle

Secondary Outcomes (9)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]

    0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal

  • Time to Reach Maximum Observed Serum Concentration (Tmax)

    0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal

  • Minimum Observed Serum Trough Concentration (Cmin)

    0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal

  • Maximum Observed Serum Concentration (Cmax)

    0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]

    0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal

  • +4 more secondary outcomes

Other Outcomes (7)

  • Human Anti-Human Antibody (HAHA) Levels

    Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal

  • Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)

    Baseline, cycle 3 and after 8 weeks

  • Time to Disease Progression

    Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37

  • +4 more other outcomes

Study Arms (1)

PF-03732010

EXPERIMENTAL

Single Arm study

Drug: PF-03732010

Interventions

PF-03732010DRUG

IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.

PF-03732010

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy
  • Age \>= 18 years of age
  • Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL, hemoglobin ≥ 9 g/dL, platelets \> 100,000/uL
  • Adequate liver function as defined by: bilirubin \< 1.5 x ULN, AST, ALT and ALP \< 2.5 x ULN, or \< 5 x ULN with documented liver and/or bone metastases
  • Serum creatinine \< 1.5 x ULN
  • ECOG status 0-1
  • Availability of biopsy tumor tissue (or fine needle aspirate) for testing of P-cadherin expression
  • Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin
  • Must be able to give written informed consent
  • Be able to comply with scheduled study visits, treatment plans, laboratory tests and other procedures

You may not qualify if:

  • Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of study entry
  • Patients with carcinomatous meningitis or untreated brain metastases.
  • History of significant low platelet count, and/or bleeding disorders, requiring medical or surgical intervention
  • History of significant bleeding episodes within 6 months, unless the source of bleeding has been resected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Parkville, Victoria, 3050, Australia

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

PF-03732010 monoclonal antibody

Limitations and Caveats

Results are not provided because development of the study drug was terminated, as neither anti-tumor activity nor pharmacodynamic modulation was observed.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2007

First Posted

November 14, 2007

Study Start

December 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 26, 2012

Results First Posted

March 26, 2012

Record last verified: 2012-02

Locations

AU(1)KR(1)US(1)